Document RanxKGqKRv8vwZaJqkeVBNOX

March 2, 1973 Dr. Lucile Adamson, Staff Scientist Mr* Scott Lang, Washington Counsel Environmental Defense Fund 1712 N Street, N.W. Washington, D.C. 20036 Dear Dr Adamson and Mr* Lang: I regret the long delay in replying to your letter about asbestos in talc* Part of the delay vas due to a heavy load of other r e s p o n s i b l e ties, and part was due to a hope that events might have proceeded to the point of resolution of the various questions involved* Even though this hope has not yet been realized, the lapse of time has been great enough to impel me to write as follows in response to your specific que tionSr Your remarks on the her.1th hazards of asbestos are of course well** founded; this has been of concern to us for some time. In August 1971 I organized a discussion, session at F M on asbestos in talc, which was attended by almost fifty representatives of industry, universities, and government. A major fccpic at the meeting was the analytical methodolog for detecting small amounts of asbestos in talc. This was recognized a a difficult problem whioh is best attacked by a battery of four methods (optical microscopy, X-ray diffraction, electron microscopy, and eleetr diffraction) and possibly a fifth method, .elemental analysis by electro microprobe. However, il was noted that the combined u3e of all the methods would be almost prohibitively expensive. One of those in attendance at the meeting was Prof. Seymour Z. Levin o New York University, a recognized expert on nineralogical chemistry anc analysis* Some time after the meeting, I asked Dr. Levin to undertake the analysis of samples of commercial talcum powder products for asbest (particularly the chrysotile and tremolite varieties) by means of the X-ray diffraction technique primarily, with additional work by optical microscopy as needed. He carried out most of this work during 1972; tc date he has examined 193 samples of talcum powders plus some miscellar ecus samples for others at F M , Drs Lewin has given us reports on his results from time to time, but wt do not yet have a truly final report from him. Until we receive it, w< cannot publicize the incomplete information in our possession. Dr. Le\ has written that the final report will be ready "within a few weeks" bx he io a very busy man and cur past experience suggests that it may not arrive until a feu months from now. i/ Page 2 Dr* Lucile Adamson and Hr, Scott Lang I hold a high regard for Dr, Lew in and the scientific quality of his w o r k ; of course, it is always necessary to maintain a critical attitude towards the results obtained by sophisticated analytical techniques. This has been particularly true In the present case, where the small amounts of asbestos involved, and the presence of transitional and alte mineralogical species, led to ambiguities in the data. In his eagernes to protect the public interest to the fullest extent, Dr, Lewin in cert cases interpreted borderline results os showing the presence of asbesto in his earlier reports, but he later used a more conservative interpret tion. He has spent a lot of time and energy in creative scientific wor aimed at resolving the ambiguities (for which the public and FDA owe hi a debt of gratitude) and he has succeeded for the most part. As you ma know, come discussion of Dr, Lewinfs earlier interpretation of the data was included in an article on asbestos in the Wall Street Journal of February 26, 1973. n Inasmuch as Dr, Lev;infs results are judged acceptable, subject to the above comments, we have not undertaken a repeat survey. Because of the possibility that optical microscopy alone may constitute an acceptable technique for the detection of asbestos in talc (and is more generally available than X-ray diffraction) we are currently making a comparison between Dr, L e w i n 1e results on selected samples find the results obtaine by in-house FDA microscopista. After this comparison work is completed a decision will be made as to the preferred procedure for detection of asbestos in talc. Details of the analytical procedure are needed for the official statement which FDA plans to i;?suc on asbestos contamina tion of talc. One more point should be noted, that FDA activities have already led to a substantial upgrading of the quality of talc used :Ln cosmetic product This is evident both from the results obtained by Dr Lewin upon reanalyses of a given product where repeat purchases wore made at retail over a period of time, and also from discussions with a principal sup plier of talc who indicates that ho now sells only asbestos-free grades of talc to the cosmetics industry, tilth reference to your last question, F M has undertaken extensive lite ture surveys on the carcinogenicity of asbestos and of talc, but the re suits thus far do not establish that talc,itself is carcinogenic. We also have had discussions with members of the national Cancer Institute where work is currently underway on carcinogenesis by fibers and minera as well as other chemicals. As you probablylrealine, the mission and facilities of the National Cancer Institute are more appropriate than those of FDA for resolving the question of the possible carcinogenicity of pure talc; also, a period of many years will be needed to obtain the answer. Page 3 ~ Dr* Lucile Adamson and Mr. Scott Lang t trust that the above information satisfies your needst and again ex press regret for the delay. . , Sincerely yours, / cc : BF-400 BF-430A BF-432 BF-433 * (BF-430) AWeissler:els 3/2/73 Alfred Vteissler, Ph.D* Acting Director Division of Colors and Cosmetics Tec) Office of Product Technology